MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY, INC. CAVUX CERVICAL CAGE-T; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number PD-31-100

Device Problem Malposition of Device (2616)

Patient Problem Neck Pain (2433)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

This event was discovered when pmt initiated a voluntary, proactive, retrospective registry of over 350 patients to explore and collect data regarding the clinical performance of pmt devices in real-world use.In this case, the event was not reported as a complaint by the customer and there was no device defect or malfunction related to the device at the time of surgery.A (b)(6)-year-old male patient underwent cervical fusion with cages placed posteriorly at c5-c7.At 2 weeks post procedure, the patient reported new radicular pain and underwent a removal of the cage at c6-c7 on the right.It is possible that the cage was malpositioned causing nerve root irritation.No device defect or malfunction was reported by the surgeon.The patient is doing well, and no subsequent issues have been reported.

Event Description

(b)(6)-year-old male patient underwent cervical fusion with cages placed posteriorly at c5-c7.At 2 weeks post procedure the patient reported new radicular pain.Cage malposition likely contributed to nerve root irritation.The patient subsequently underwent a removal of the cage at c6-c7 on the right and lateral mass screw placement at that level.No device defect or malfunction was reported by the surgeon.

• Brand Name: CAVUX CERVICAL CAGE-T
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton CA 94588
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton CA 94588
• Manufacturer Contact: janie mandrusov ; 3875 hopyard rd; suite 300; pleasanton, CA 94588 ; 4153013128
• MDR Report Key: 9146369
• MDR Text Key: 162091982
• Report Number: 3009394448-2019-00014
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PD-31-100
• Device Catalogue Number: PD-31-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR